Site Management Associate I

PSI CRO is a global company dedicated to improving medical science and the quality of work in the clinical research industry. They are seeking a Site Management Associate I to ensure effective communication and documentation exchange with sites and vendors, manage clinical supplies, and support training and safety management for site teams.

Responsibilities

• Ensures exchange of information and documentation with sites and vendors
• Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
• Ensures regulatory and ethics committee submissions and notifications
• Ensures proper administration of sites and vendors payments
• Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
• Reviews and coordinates site-specific query resolution
• Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status
• Exchanges information and documentation with other departments
• Supports the organization of internal team meetings including preparation of agendas and minutes
• Supports the organization of Investigator Meetings
• Maintains study-specific and corporate tracking systems
• Serves as the sites’ primary contact point
• Serves as the primary sites’ contact point for vendors, study supplies, and access management
• Ensures communication between the sites and off-site facilities
• Arranges and tracks initial and on-going project training for site teams in all vendor-related systems
• Provides training in courier management and study supplies ordering to the site team
• Checks the TMF on a site and a country level regularly and files pending documents
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit
• Revises and checks translations status
• Ensures proper safety information flow with the investigative sites
• Updates CTMS with lacking project information
• Assists the Monitors in their prompt completion of all subject event and site event information in CTMS
• Assists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMS
• Tracks the resolution status of site issues and action items in CTMS
• Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
• Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level
• Other departmental assignments, as necessary

Company

• Global full-service contract research organization with predictable patient enrollment
• Zug, Zug, CHE
• https://www.psi-cro.com/
• Founded in 1995
• 1001-5000 employees

Qualifications

• College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient
• Minimum 2 year experience within the clinical research industry, corporate or academic environment where administrative experience and technical skills have been gained
• Basic proficiency in MS Word
• Basic proficiency in MS Excel
• Basic proficiency in MS Outlook
• Basic proficiency in MS Power Point
• Knowledge (following proper training) of applicable software and project specific systems
• Basic typing skills in English (min. 40 words per minute)
• Glassdoor
• 4.2
• PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
• Zug, Zug, CHE
• https://www.psi-cro.com/
• Late Stage
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Required skills

• Clinical Research, MS Excel, MS Outlook, MS PowerPoint, MS Word, Typing

Experience

• 2+ years